Related Experiment Video

Updated: Aug 14, 2026

Protocol for Recombinant RBD-based SARS Vaccines: Protein Preparation, Animal Vaccination and Neutralization Detection
12:09

Protocol for Recombinant RBD-based SARS Vaccines: Protein Preparation, Animal Vaccination and Neutralization Detection

Published on: May 2, 2011

Vaccines: World Health Organization versus Federal Drug Administration recommended formula

M K Khalil1, Y Y al-Mazrou, Y S al-Ghamdi

  • 1King Fahad Specialist Hospital, Buraydah, Saudi Arabia.

Eastern Mediterranean Health Journal = La Revue De Sante De La Mediterranee Orientale = Al-Majallah Al-Sihhiyah Li-Sharq Al-Mutawassit
|January 17, 2002
PubMed

Insights

Infant vaccines using FDA formulas showed higher antibody levels for tetanus and diphtheria compared to WHO formulas, despite lower antigen concentrations. Oral poliovirus vaccine immunogenicity remained comparable between the two vaccine formulations.

Area of Science:

  • Immunology
  • Vaccinology
  • Pediatrics

Background:

  • Vaccine formulations can differ significantly between global regulatory standards (WHO) and national standards (FDA).
  • Understanding the immunogenicity of different vaccine concentrations is crucial for public health policy and vaccine efficacy.

Purpose of the Study:

  • To compare the immunogenicity of vaccines prepared according to WHO and FDA formulas in infants.
  • To assess antibody responses to Haemophilus influenzae type b, diphtheria, tetanus, and poliovirus antigens.

Main Methods:

  • A randomized trial involving 6-week-old infants receiving three doses of vaccines (Haemophilus influenzae type b, diphtheria-tetanus-pertussis, oral polio) at specified intervals.
  • Antibody levels (polyribosylribitol phosphate, tetanus, diphtheria, poliovirus) were measured one month post-vaccination.

Main Results:

  • Infants receiving the FDA-formula vaccine exhibited significantly higher anti-tetanus and anti-diphtheria antibody levels compared to those receiving the WHO-formula vaccine.
  • Despite having half the concentration of diphtheria and tetanus antigens, the FDA formula elicited a stronger response.
  • No significant differences in immunogenicity were observed for the oral poliovirus vaccine between the two groups.

Conclusions:

  • FDA-formulated vaccines demonstrate superior immunogenicity for diphtheria and tetanus antigens compared to WHO-formulated vaccines in infants.
  • Vaccine formulation and antigen concentration play a critical role in eliciting robust immune responses.
  • Further research may be warranted to optimize global vaccine formulations for enhanced pediatric immune protection.

More Related Videos

Opsono-Adherence Assay to Evaluate Functional Antibodies in Vaccine Development Against Bacillus anthracis and Other Encapsulated Pathogens13:47

Opsono-Adherence Assay to Evaluate Functional Antibodies in Vaccine Development Against Bacillus anthracis and Other Encapsulated Pathogens

Published on: May 19, 2020

Fabrication of Pulsatile Polymeric Microparticles Encapsulating Rabies Antigen07:44

Fabrication of Pulsatile Polymeric Microparticles Encapsulating Rabies Antigen

Published on: May 12, 2023

Related Concept Videos

Vaccinations01:51

Vaccinations

Overview
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
Vaccines01:21

Vaccines

Vaccines are among the most effective tools in preventive medicine, designed to prepare the immune system to recognize and combat infectious agents. By introducing antigens—substances that the immune system identifies as foreign—vaccines stimulate an adaptive immune response that leads to immunological memory. This immunological memory enables the body to mount a faster and more effective response upon future exposures to the actual pathogen.Vaccines can be categorized based on the type of...